Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 640
- Locations
- 2
- Primary Endpoint
- Clinical performance assessment
Study Overview
Brief Summary
In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 5 years or older
- •Presenting at the study site with symptoms and signs suggestive of malaria
- •Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
- •Willing to provide sample at enrolment
Exclusion Criteria
- •Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Outcomes
Primary Outcomes
Clinical performance assessment
Time Frame: up to 6 months
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Concordance
Time Frame: up to 6 months
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
Secondary Outcomes
No secondary outcomes reported